Female urinary incontinence device

ABSTRACT

A female urinary incontinence device is provided for preventing uncontrolled flow of urine. The device is in the form of a hollow plastic tube having an open proximal end for insertion into the bladder and a control device at the distal for controlling the flow of urine. The proximal end has an extensible and retractable mushroom shaped plastic which maintains the device in the bladder.

FIELD OF THE INVENTION

The present invention relates to a female intraurethral urinaryincontinence device. More particularly, there is provided a softsemi-collapsible urinary incontinence device which can be inserted andactivated for drainage by the user.

BACKGROUND OF THE INVENTION

The female urethra is two inches long. It is situated between the twolabia and at the entrance of the vaginal tract. It is anatomicallydifficult or impossible to place an external device on the urethra. Inthe male, the presence of the penis will facilitate placing an externaldevice around the penis if the male patient is incontinent. Therefore,incontinent female patients uses pads or diapers to conceal theirincontinence problem. Sometimes they have a permanent indwellingcatheter. In young incontinent females, sexual intercourse is almostimpossible.

It is therefore desirable to have a device that will prevent leakage ofthe urine, in addition, the female can have a normal life includingintercourse, pregnancy and delivery without the smell of urine or thehazard of an indwelling catheter.

It is ideal that this device is soft and in a semi-collapsed state. Thedevice thus will be less irritant and can be easily tolerated. Thedevice should be completely concealed and does not interfere with sexualintercourse, pregnancy or delivery. The device should be easily insertedby the female patient, controlled by the patient and removed by thepatient at any time she wishes to do so.

SUMMARY OF THE INVENTION

The present invention relates to a female urinary incontinence catheteror device. The device comprises a hollow tube having an open proximalend and an open distal end. At the proximal end is an extensible meansfor insertion and maintaining the device in the bladder. At the distalend is a means for controlling the flow of urine from the bladder. Thecontrol means comprises a valve which is normally closed to prevent theflow of urine and is manually opened to allow the flow of urine.

Advantageously, the valve means contains offset apertures which whenaligned can permit urine flow or an insertion of a means for extendingthe maintenance means for inserting into the urinary tract.

Preferably, the hollow tube is soft and semi-collapsible so as toprovide comfort for long periods of time.

It is a general object of the invention to provide a device forcontrolling female urinary incontinence.

It is another object of the invention to provide a female incontinencedevice which can be inserted and/or removed by the patient.

It is yet another object of this invention to provide a softsemi-collapsed catheter that is completely concealed by the incontinentfemale patient.

It is a further object of this invention to provide a hollow tube thatdrains the bladder by a mechanism activated by the female patient.

It is still a further object of this invention to provide a simple wayto keep the catheter indwelling and could be removed by the femalepatient at any time she wishes to do so.

It is yet another object of this invention to provide methods tominimize and prevent the migration of the device into the bladder.

These and other objects of the instant invention will become obviousfrom the description of the invention contained herein and moreparticularly with reference to the following detailed description of theinvention and the drawings where like elements are referred to by likereference numbers.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the female urinary incontinence deviceof the invention together with an applicator in an extended position;

FIG. 2 is the device of FIG. 1 in a retracted position;

FIG. 3 is a cross-sectional view of the mechanical timer control;

FIG. 4 is a top view of the timer control of FIG. 3;

FIG. 5 shows the bottom part of the timer control of FIG. 3;

FIG. 6 is a cross-sectional view of a female urinary incontinence deviceof the invention with a flow control valve in the open position;

FIG. 7 is a cross-sectional view of the device of FIG. 6 with the flowcontrol valve in the closed position; and

FIG. 8 is an enlarged cross-sectional view of the valve of FIG. 7.

The invention above has been described in connection with specificembodiments. It is to be understood, however that the particulardescriptions contained herein is for the purpose of illustration and notfor the purpose of limitation. Changes and modifications may be made tothe description contained herein and still be within the scope of theclaimed invention. Further, obvious changes and modifications will occurto those skilled in the art.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

As shown in FIGS. 1 and 2, the female urinary incontinence catheter ordevice 10 has an elongated hollow tube 11. At the proximal end of thetube 11 is a flexible plastic member 16 which is normally in a retractedmushroom shape. The member 16 can be extended by use of an applicator 12having a rod 13 which passes through the tube 11 and pushes against thereinforced tip 17 of the member 16. In the extended position the device10 can be placed into the bladder. When she applicator 12 is removed themember 16 will retract into its normal balloon or mushroom shape and bemaintained within the bladder. To remove the device 10 the patientreinserts the applicator into the tube 10 and extends member 16.Preferably, the rod 13 is hollow so that when the tip is inside thebladder urine will come out indicating that the proximal end is withinthe bladder.

At the proximal end of the tube 10 there is also a soft elastomeric seal18 which prevents leakage from the bladder.

At the distal end of the tube 10 there is a urine control means 14 whichis manually operated by the patient so as to permit the flow of urineout of the tube or to reinsert the applicator 12 to remove the device10.

FIGS. 3-5 illustrate the control means 14 with a timing mechanism thatcan be formed by a rotating timing spring control valve or system 20 orother suitable valve which has a soft elastomeric coating. The timercontrol system 20 is constructed in two sections which contain twoapertures 21a and 22a which are aligned as seen in FIG. 4 so as to allowurine to flow out of the tube or to insert the applicator 12 with therod 13 therethrough. The part 21 can be manually rotated to place theaperture 21a in alignment with the aperture 22a on part 22. The timingspring 20 will rotate part 21 so that the apertures 21a and 22a are nolonger aligned so as to close the system and prevent urine flow.

The outer portion of control means 14 and the seal 18 should be of softelastomeric material so as to be comfortable for the patient whennormally used and during sexual intercourse. Non-porous expandedpolytetrafluoroethylene or similar material may be used. Pharmacologicalsilicone or latex elastomers are other such elastomeric members whichcan be used.

The tube 11 should also be formed from a soft deformable plastic such asa polyolefin, i.e. polyethylene and polypropylene. The tube 11 may befully collapsible but sufficiently open to permit urine flow.

The proximal end member 16 can be integral with the tube 11 or attachedthereto. One form of the member 16 may be formed by cutting longitudinalslits in the tube and then providing the slits with a memory while in aretracted and mushroom shape such as by heating.

The applicator 12 can comprise a plastic or metal hollow rod which has aplastic gripping member on the end.

FIGS. 6-8 illustrate a female incontinence device 30 of the inventionwith a novel urine control valve 33. The device 30 has an elongated tube39 having at the proximal end a flexible plastic member 32 which can beextended or retracted into a mushroom shape as shown. At the proximalend is also an elastomeric seal 31.

At the distal end of the tube 39 is the urine control valve 33. In FIG.6, the valve 33 is shown in the open position with access into the tube39 through opening 36 for insertion of the applicator 12. Generally, inthe closed position the valve 33 is about one inch in length and in theclosed position about 1/2 inch in length. The valve 33 has a pair ofelastomeric seals 34, 35 and accordion type pleats 38, 40. As shown inFIG. 8, the pleats form a plurality of seals 37 along its length toprevent urine flow. The length of the device shown in FIG. 7 isgenerally about 3 to 4 inches.

Method Of Use

The device 10 can be inserted through the urethra into the bladder bythe patient with the applicator 12 in position as shown in FIG. 1. Whenthe device is sufficiently inserted urine will come out of the bladder.The applicator 12 is then removed and the control means 14 is moved intothe closed position. The proximal end member 16 becomes mushroom shapedand prevents the device from shipping out of the bladder. When member 16becomes mushroom shaped it forms the seal with the soft elastomericsealing means 18. In order for the patient to empty her bladder she willmanually activate the control means 14 so that there is an opening forthe urine to flow. Preferably, the control means 14 comprises a timer asin FIGS. 3-5 which maintains the opening for the urine to flow 30 to 45seconds.

The most preferred controlled valve system is seen in FIGS. 6 and 7.This accordion type of valve is simple to activate by merely separatingtwo donut shape and soft elastomer 34, 35. This is important in patientswith nervous disability. Another advantage of this preferred valvesystem is that when the pressure in the bladder rises to a dangerouslevel i.e., in patients who have no sensation, the valve willautomatically open. This will prevent back pressure damage to thekidneys.

It is to be understood, however, that even though specificcharacteristics and advantages of the present invention have been setforth in the foregoing description, together with details of thestructure and function of the invention, it will be appreciated that thedisclosure is illustrative only, and that changes may be made in detail,especially in matters of shape, size, arrangement of parts or sequenceor elements of events within the principles of the invention to the fullextent indicated by the broad general meaning of the terms in which theappended claims are expressed.

What is claimed is:
 1. A female urinary incontinence device to be placedin a patient's urinary tract, comprising:a hollow plastic tube having anopen proximal end and an open distal end; an expandable member adjacentsaid proximal end for maintaining said device within the patient'sbladder: and, an accordion type valve having a plurality of pleats and avalve passage and being disposed adjacent said distal end forcontrolling flow of urine from the patient's bladder through said valvepassage, said valve being normally closed to prevent a flow of urine andmanually opened to allow the flow of urine, said valve forming aplurality of seals in said valve passage when said valve is in a closedposition.
 2. The device of claim 1 wherein said plurality of pleats aredisposed between a pair of elastomeric seals.
 3. A female urinaryincontinence device to be placed in a patient's urinary tract,comprising:a hollow deformable soft plastic longitudinally extended tubehaving an open proximal end and an open distal end, said tube having anextensible mushroom shaped portion formed adjacent said proximal end formaintaining said device in the patient's bladder: an elastomeric sealdisposed adjacent said mushroom shaped portion of said tube forpreventing leakage of urine from the patient's bladder: a pair ofelastomeric members disposed adjacent said distal end of said tube inlongitudinally spaced relationship; and, an elastomeric manuallyoperable urine control valve disposed between said pair of elastomericmembers and having an open position and a closed position forcontrolling urine flow through a valve passage, said control valveincluding an accordion type pleated portion forming a plurality of sealsin said valve passage responsive to said valve being in said closedposition.